The Food and Drugs Act (FDA) and its regulations give Health Canada the authority to regulate food, drugs (including natural health products), medical devices and cosmetics. Our role as a regulator is to verify that regulatory requirements for the safety and effectiveness of medical devices are met. We do this through a combination of pre-market scrutiny, post-market surveillance and compliance and enforcement activities.
The MDR uses a risk-based approach to regulating medical devices. The safety and effectiveness evidence required by these regulations to support a licence application is in proportion to the risk presented by the device.
This approach balances 2 needs:
- the need to provide people in Canada with timely access to new and innovative technology
- the need for appropriate levels of pre-market oversight of safety and effectiveness evidence
Since 1998, under section 36 of the MDR, Health Canada may impose T&Cs on a Class II to IV medical device licence. T&Cs are used as regulatory tools to help ensure that medical devices in Canada continue to meet the safety and effectiveness requirements outlined in sections 10 to 20 of the MDR.
